Medical Device Manufacturer · US , Indianapolis , IN

Roche Diagnostics Corp. - FDA 510(k) Cleared Devices

264 submissions · 263 cleared · Since 1999

264

Total

263

Cleared

1

Denied

FDA 510(k) cleared devices by Roche Diagnostics Corp. Pathology ✕

2 devices

1-2 of 2

Cleared Dec 18, 2003

FACTOR II (PROTHROMBIN) G20210A KIT

Pathology · 31d

Not Cleared Dec 17, 2003

FACTOR V LEIDEN KIT

DEN030005 · NPQ

Pathology · 9d